| September 21, 2005 |
| June 5, 2007 |
| November 2004 |
| |
| Hamilton Depression Rating Scale, 24 items (HDRS) [ Time Frame: 10 weeks ] |
| Hamilton Depression Rating Scale, 24 items (HDRS) |
| Complete list of historical versions of study NCT00225251 on ClinicalTrials.gov Archive Site |
- Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ]
- Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ]
- Clinical Global Impressions (CGI) [ Time Frame: 10 weeks ]
- Global Assessment of Functioning Scale (GAFS) [ Time Frame: 10 weeks ]
- Patient-CGI (CGI-P) [ Time Frame: 10 weeks ]
- Social Adjustment Scale (SAS) [ Time Frame: 10 weeks ]
- Symptom Checklist (SCL-90-R) [ Time Frame: 10 weeks ]
- Temperament and Character Inventory (TCI) [ Time Frame: 10 weeks ]
- Medical Outcomes Study- HIV – Cognitive Scale (MOS-HIVcs) [ Time Frame: 10 weeks ]
- Aldenkamp-Baker Neurotoxicity Scale (ABS) [ Time Frame: 10 weeks ]
- Arizona Sexual Experiences Scale (ASEX) [ Time Frame: 10 weeks ]
|
- Cornell Dysthymia Rating Scale (CDRS)
- Beck Depression Inventory (BDI)
- Clinical Global Impressions (CGI)
- Global Assessment of Functioning Scale (GAFS)
- Patient-CGI (CGI-P)
- Social Adjustment Scale (SAS)
- Symptom Checklist (SCL-90-R)
- Temperament and Character Inventory (TCI)
- Medical Outcomes Study- HIV – Cognitive Scale (MOS-HIVcs)
- Aldenkamp-Baker Neurotoxicity Scale (ABS)
- Arizona Sexual Experiences Scale (ASEX)
|
| |
| Wellbutrin XL for Dysthymic Disorder |
| Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL |
This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo. |
This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet DSM-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Dysthymic Disorder |
| Drug: bupropion XL |
| |
| Hellerstein DJ, Batchelder S, Kreditor D, Fedak M. Bupropion sustained-release for the treatment of dysthymic disorder: an open-label study. J Clin Psychopharmacol. 2001 Jun;21(3):325-9. |
| |
| Completed |
| 60 |
|
|
Inclusion Criteria:
- Male and female outpatients 18-65 years of age.
- Patients with a DSM-IV diagnosis of dysthymic disorder, early onset.
- Patients will have a total score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.
Exclusion Criteria:
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00225251 |
|
| gsk 102149 |
| St. Luke's-Roosevelt Hospital Center |
| GlaxoSmithKline |
| Principal Investigator: |
David J. Hellerstein, MD |
St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute |
|
|
| St. Luke's-Roosevelt Hospital Center |
| June 2007 |